FDA Clarifies Information About Payment and Reimbursement to Research Subjects
The US Food and Drug Administration (FDA) has published updates to the Payment for Research Subjects Information Sheet to clarify that reimbursement for travel expenses to and from the clinical trial site and associated costs such as airfare, parking, and lodging are acceptable under current practices.
This update is in response to inquiries the FDA has received from stakeholders about appropriate reimbursement practices. The title of this information sheet has been revised to reflect these changes. The new title is Payment and Reimbursement to Research Subjects.
Per 21 CFR 56.111(a)(2), the Institutional Review Board (IRB) should determine that the risks to subjects are reasonable in relation to anticipated benefits and that the consent document contains an adequate description of the study procedures [21 CFR 50.25(a)(1)] as well as the risks [21 CFR 50.25(a)(2)] and benefits [21 CFR 50.25(a)(3)].
According to the FDA, paying research subjects in exchange for their participation is a common and, in general, acceptable practice. Payment to research subjects for participation in studies is not considered a benefit that would be part of the weighing of benefits or risks; it is a recruitment incentive.
The FDA notes that payment for participation may raise difficult questions that should be addressed by the IRB. For example, how much money should research subjects receive, and for what should subjects receive payment, such as their time, inconvenience, discomfort, or some other consideration.
In contrast to payment for participation, the FDA does not consider reimbursement for travel expenses to and from the clinical trial site and associated costs such as airfare, parking, and lodging to raise issues regarding undue influence. Other than reimbursement for reasonable travel and lodging expenses, IRBs should be sensitive to whether other aspects of proposed payment for participation could present an undue influence, thus interfering with the potential subjects’ ability to give voluntary informed consent.
Payment for participation in research should be just and fair. The amount and schedule of all payments should be presented to the IRB at the time of initial review. The IRB is responsible for reviewing both the amount of payment and the proposed method and timing of disbursement to assure that neither are coercive or present undue influence [21 CFR 50.20].
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